PHASE II RENAL CASE STUDY

SITUATION

A Sponsor approached CRMG regarding a Phase II study of a novel phosphate binder previously approved for use in end stage renal patients on dialysis.  The Sponsor’s objective was to generate data to support expanding the label claim for this product to encompass chronic kidney disease (CKD) patients not on dialysis.

SOLUTION

1. Therapeutic experience:  Upon initial review of the protocol and CRMG’s knowledge of hemodialysis patients, CRMG identified potential enrollment challenges based on the strict inclusion/exclusion criteria for the study.  The Sponsor initially did not want to change the protocol since this was the first study in a new population.  Alternatively, CRMG proposed the development of a highly detailed and customized enrollment tracking system based on a multitude of variables to act as an early signal of potential enrollment issues.
2. Attention to detail a proactive approach:  Given CRMG’s sensitivity to the enrollment challenges that were likely to occur, the team performed daily updates and review of data using the custom tracking system.  In anticipation of the possible need for more sites, CRMG proactively performed additional feasibility/site identification activities, keeping the team well-poised to address the expansion of sites when needed. The tracking system identified very early in the study that the number of screen failures was greater than originally estimated, with the collected data ultimately providing the supporting evidence to justify a major protocol amendment.
3. Flexibility when it counts:  In order to provide the Sponsor with critical screening data in real time, CRMG modified the custom tracking system to include additional data that could not easily be downloaded and integrated from the central laboratory and electronic data capture systems.  This was a laborious task requiring daily, manual, subject-by-subject updates using data from a number of different systems.  The CRMG project team managed this tracking system throughout the remainder of the study which proved to be essential to the study’s success. 
4. Agility & support when it matters:  While the Sponsor finalized the protocol amendment, CRMG identified and initiated additional sites to support enrollment efforts under the amended protocol, increasing the number of sites by 75%. With a focus on client satisfaction, CRMG’s project team worked tirelessly to qualify and initiate these new sites in a matter of weeks. CRMG also developed a number of innovative study tools and dosing guidelines for the investigative sites to aide both the sites and study subjects with compliance.

RESULTS

At the outset of the study, the sponsor’s goal was to enroll 84 patients in 12 months.   Based on CRMG’s proactive actions and efficient efforts, we were able to close the study ahead of schedule, despite the significant increase in the number of sites and investigator level support.  Further, the data collected in the study formed the basis for an FDA Advisory Committee meeting on broadening the indication from dialysis patients to patients with earlier stages of kidney disease, which the committee voted in favor of. 

Therapeutic knowledge, flexibility, proactive planning and the ability to respond to change are not new concepts for ensuring a successful study. It’s finding a partner who can live up to these attributes that is the real challenge.

- Just another example of how CRMG was prepared to deliver!